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Provisions on Medical Device Registration
2015-08-01 14:31

CFDA Order

No. 4

It is hereby announced that the Provisions on Medical Device Registration has been adopted by CFDA at the administration affairs meeting on June 27, 2014, and shall apply from October 1, 2014.

                                      

Director General: Zhang Yong

July 30, 2014

 

Provisions on Medical Device Registration

Chapter I - General Provisions

Article 1 These Provisions have been formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices to standardize the administration of medical device registration & recording and ensure the safety and effectiveness of medical devices.

Article 2 Any medical device to be distributed and used within the territory of the People's Republic of China shall be approved (through registration/recording) in accordance with these Provisions.

Article 3 “Medical device registration” is a process in which the Food and Drug Administration authority systematically evaluates the safety and effectiveness of the medical device to be placed on the market based on the application submitted by the medical device registration applicant in accordance with legal procedures so as to decide whether or not to approve the registration application.

 “Medical device recording” is a process in which the medical device recording applicant submits recording dossiers to the Food and Drug Administration authority, and the Food and Drug Administration authority archives the recording dossiers submitted by the recording applicant for future reference.

Article 4 Medical device registration and recording shall follow the principles of openness, fairness and impartiality.

Article 5 Class I medical devices shall be regulated through recording. Class II and Class III medical devices shall be regulated through registration.

For the recording of a domestic Class I medical device, the recording applicant shall submit recording dossiers to the Food and Drug Administration authority at the level of city with sub-districts.

The application for registration of a domestic Class II medical device shall be reviewed and approved by the Food and Drug Administration authority at the level of province, autonomous region or municipality, and the Medical Device Registration Certificate shall be issued after approval.

The application for registration of a domestic Class III medical device shall be reviewed and approved by CFDA, and the Medical Device Registration Certificate shall be issued after approval.

For the recording of an imported Class I medical device, the recording applicant shall submit recording dossiers to CFDA.

The application for registration of an imported Class II/III medical device shall be reviewed and approved by CFDA, and the Medical Device Registration Certificate shall be issued after approval.

The application for registration/recording of a medical device manufactured in Hong Kong, Macao or Taiwan shall be dealt with by referencing to the registration/recording requirements for an imported medical device.

Article 6 The Marketing Authorization Holder (MAH) of a medical device is the one who places the medical device on the market in its own name and bears the legal responsibility for the device.

Article 7 The Food and Drug Administration authorities shall timely publish relevant information on medical device registration and recording according to law. The applicant shall have access to the approval progress and results. The approval results shall also be accessible to the public.

Article 8 The State encourages research and innovation of medical devices and implements expedited approval procedures for innovative medical devices, with a view to promoting the popularization and application of new medical device technologies and pushing forward the development of medical device industry.

 

Chapter II - General Requirements

Article 9 The medical device registration/recording applicant shall establish a Quality Management System (QMS) related to product development and manufacturing and shall keep the effective operation of the System.

As for the application for registration of a domestic medical device in accordance with the Expedited Approval Procedures for Innovative Medical Devices, in case of contract manufacturing of samples, the entrusted medical device manufacturing enterprise shall have the Manufacturing License covering the corresponding manufacturing scope. As for the application for registration of a domestic medical device in accordance with the normal procedures, the applicant shall not entrust the manufacturing of samples to other manufacturing enterprise(s).

Article 10 The personnel handling the medical device registration or recording shall be equipped with appropriate expertise and be familiar with the laws, regulations, rules, and technical requirements related to the administration on the medical device registration or recording.

Article 11 When applying for registration or recording, the registration/recording applicant shall comply with the basic requirements for the safety and effectiveness of medical devices and ensure the standardization of product development process, and the authenticity, completeness and traceability of all data.

Article 12 The dossiers for registration or recording application shall be in Chinese. For those Chinese materials translated from materials in a language other than Chinese, the original texts shall be provided at the same time. Where unpublished literatures are cited, the document certifying the licensed use of these literatures issued by the owner shall be provided.

The registration/recording applicant shall be responsible for the authenticity of the dossiers submitted.

Article 13 An imported medical device to be registered or recorded in China shall have been approved to enter the market in the country (or region) where the registration place or the manufacturing site of the registration/recording applicant is located.

If the product is not regulated as a medical device in the country (or region) where the registration place or the manufacturing site of the registration/recording applicant is located, the registration/recording applicant shall provide relevant supporting documents, including the supporting documents certifying that this product has been approved to enter the market in the country (or region) where the registration place or the manufacturing site of the registration/recording applicant is located.

Article 14 The overseas registration/recording applicant shall entrust its representative office within the territory of the People's Republic of China as its Agent or designate a corporate body within the territory of the People's Republic of China as its Agent. The Agent shall work with the overseas registration/recording applicant to carry out related work.

In addition to handling matters concerning medical device registration or recording, the Agent shall also assume the following responsibilities:

(1)    To communicate with the corresponding Food and Drug Administration authority in China and the overseas registration/recording applicant;

(2)    To truthfully and accurately convey the relevant laws and regulations and technical requirements to the registration/recording applicant;

(3)    To collect post-marketing adverse events, feed back to the overseas MAH and meanwhile report to the corresponding Food and Drug Administration authority in China;

(4)    To coordinate the recall of medical devices after they are approved to enter the Chinese market, and report to the corresponding Food and Drug Administration authority in China;

(5)    To assume joint liability together with the overseas MAH concerning product quality and after-sales service.

 

Chapter III - Product Technical Requirements (PTR) and Product Test for Registration Application

Article 15 The registration/recording applicant shall prepare the PTR for the medical device to be registered or recorded. The PTR of a Class I medical device shall be submitted by the recording applicant to the Food and Drug Administration authority during the recording application. The PTR of a Class II/III medical device shall be reviewed and approved by the Food and Drug Administration authority during registration application.

The PTR mainly includes performance indicators and test methods of the finished medical device; and the performance indicators refer to the functional indicators and safety indicators of the finished device that can be determined objectively and other indicators related to the quality control.

Medical devices distributed and used in China shall accord with the approved (through registration/recording) PTR.

Article 16 With the purpose of registration application, a Class II/III medical device shall be tested in a medical device testing institute based on the PTR.

The test samples shall be manufactured in accordance with relevant QMS requirements. Clinical trials or registration application can be conducted only after the device is proved to be up-to-standard through tests.

As for the application for recording of a Class I medical device, the recording applicant may submit a self-test report.

Article 17 When applying for product tests, the applicant shall provide the testing institute with the required technical data, test samples and the PTR.

Article 18 Medical device testing institutes shall have the corresponding qualifications, conduct tests only for the medical devices that are included in their approved testing scope, and carry out a pre-assessment of the PTR submitted by the applicant. The pre-assessment opinions shall be issued to the applicant along with the product test report.

A medical device that has not yet been included in the testing scope of any medical device testing institute shall be tested by a testing institute with appropriate competence designated by the corresponding authority responsible for the review and approval of the registration application.

Article 19 The safety and effectiveness of the product(s) tested shall be able to represent the safety and effectiveness of other products in the same registration unit.

 

Chapter IV - Clinical Evaluation

Article 20 “Medical device clinical evaluation” is a process in which the registration/recording applicant verifies whether the product meets the requirements for clinical use or its scope of application through clinical literatures, clinical experiential data, clinical trials and other information.

Article 21 “Clinical evaluation data” refers to the documents produced by the registration/recording applicant during clinical evaluation.

For a medical device requiring clinical trials, the clinical evaluation data submitted shall include the clinical trial protocol and the clinical trial report.

Article 22 As for the application for recording of a Class I medical device, clinical trials are not required. As for the application for registration of a Class II/III medical device, clinical trials shall be conducted.

Under any of the following circumstances, clinical trials may be exempted:

(1)    The medical device to be registered has clear working mechanism, finalized design and mature manufacturing process; the predicate device (similar device already on the market) has been in clinical application for many years without severe adverse events; and the medical device to be registered doesn't change the general purposes;

(2)    The safety and effectiveness of the medical device to be registered can be proved through non-clinical evaluation;

(3)    The safety and effectiveness of the medical device to be registered can be proved through the analysis and evaluation on the data obtained from the clinical trials or clinical applications of the predicate device.

The Catalogue of Medical Devices Exempted from Clinical Trials shall be formulated, adjusted and promulgated by CFDA. Where the safety and effectiveness of the medical device to be registered that is not covered by the Catalogue of Medical Devices Exempted from Clinical Trials can be proved through the analysis and evaluation on the data obtained from the clinical trials or clinical applications of the predicate device, the applicant may give explanations and submit relevant supporting materials during the registration application.

Article 23 Medical device clinical trials shall be conducted in the certified clinical trial institutions in accordance with the requirements of the Good Clinical Practice for Medical Devices. The samples used for clinical trials shall be manufactured in accordance with relevant QMS requirements.

Article 24 Clinical trials for Class III high-risk medical devices shall be approved by CFDA before initiation. The Catalogue of Class III High-Risk Medical Devices Requiring CFDA Approval for Clinical Trials shall be formulated, adjusted and promulgated by CFDA.

Article 25 “Review and approval of clinical trials” is a process in which CFDA makes a comprehensive analysis on the level of risk, clinical trial protocol, and clinical benefit-risk comparative analysis report of the investigational medical device based on the information submitted by the applicant so as to decide whether the clinical trials are allowed for initiation or not.

Article 26 Where the clinical trials of a medical device are required to be reviewed and approved by CFDA, the applicant shall submit the application dossiers to CFDA in accordance with relevant requirements.

Article 27 After accepting the application for review and approval of clinical trials of a medical device, CFDA shall forward application dossiers to its Center for Medical Device Evaluation (CMDE) within 3 working days upon the date of application acceptance.

The CMDE shall complete the technical review within 40 working days. CFDA shall make a decision within 20 working days after the conclusion of the technical review. If the clinical trials are approved for initiation, a letter of approval shall be issued to the applicant; if the clinical trials are not approved for initiation, a written justification for disapproval shall be provided.

Article 28 Where supplements and corrections are required to be made by the applicant during the technical review, the CMDE shall, on a single occasion, inform the applicant of all the contents that need to be supplemented and corrected. The applicant shall provide the supplementary dossiers one time as required within one year based on the Notice of Supplementation and Correction. The CMDE shall complete the technical review within 40 working days upon the date of receiving supplementary dossiers. The expiry of the period laid down for the technical review shall be suspended from the date of the Notice of Supplementation and Correction until such time as the supplementary dossiers have been received.

If the applicant fails to submit the supplementary dossiers within the time limit, the CMDE shall terminate the technical review and put forward the suggestions of not approving the application, and CFDA shall make the final decision of disapproval after ratifying the suggestions put forward by the CMDE.

Article 29 Under any of the following circumstances, CFDA shall revoke the letter of approval that has been issued for clinical trials of a medical device:

(1)    The application dossiers are false;

(2)    The latest studies have confirmed that there are problems in the ethical and scientific nature of the approved clinical trials.

(3)    Other circumstances under which the letter of approval shall be revoked.

Article 30 The clinical trials of a medical device shall be carried out within three years after being approved. If the clinical trials fail to be carried out within the time limit, the original approval letter shall automatically become invalid; in this case, re-application will be required if the clinical trials still need to be carried out.

 

Chapter V - Product Registration

Article 31 To apply for medical device registration, the applicant shall submit application dossiers to the Food and Drug Administration authority in accordance with the relevant requirements.

Article 32 After receiving the application, the Food and Drug Administration authority shall conduct a formal examination on the application dossiers and deal with the application according to the following circumstances:

(1)    The application shall be accepted if the items of application fall within the purview of the Food and Drug Administration authority and the application dossiers are complete and meet the requirements of formal examination;

(2)    The applicant shall be allowed to correct the mistakes existing in the application dossiers that can be corrected on the spot;

(3)    If the application dossiers are incomplete or fail to meet the requirements of formal examination, the Food and Drug Administration authority shall, on a single occasion, inform the applicant of all the contents that need to be supplemented and corrected within five working days; in case of failure to inform the applicant within the time limit, the Food and Drug Administration authority shall be deemed to have accepted the application from the date of receipt of the application dossiers;

(4)    If the items of application do not fall within the purview of the Food and Drug Administration authority, the applicant shall be informed immediately that the application will not be accepted.

The Food and Drug Administration authority shall issue a Notice of Acceptance when accepting the application or a Notice of Non-Acceptance when refusing the application, affixed with the official seal of the authority and indicated with the date.

Article 33 The Food and Drug Administration authority that accepts the registration application shall forward the application dossiers to its Center for Medical Device Evaluation within three working days upon the date of acceptance.

The Center for Medical Device Evaluation shall complete the technical review of the registration application for a Class II medical device within 60 working days and for a Class III medical device within 90 working days.

If an external expert review is needed during the technical review or a joint review together with the Center for Drug Evaluation is needed for a drug-device combination product, the time required shall not be included in the period laid down for the technical review. The Center for Medical Device Evaluation shall inform the applicant in writing of the time required.

Article 34 The Food and Drug Administration authority has the right to access the original research data during the technical review and organize the QMS audit concerning the product development and manufacturing activities of the applicant.

The QMS audit for a domestic Class II/III medical device to be registered shall be carried out by the Food and Drug Administration authority at the level of province, autonomous region or municipality. In the case of the QMS audit for a domestic Class III medical device to be registered, the CMDE of CFDA shall inform the corresponding Food and Drug Administration authority at the level of province, autonomous region or municipality to carry out the audit, and shall participate in the audit when necessary. The Food and Drug Administration authority at the level of province, autonomous region or municipality shall complete the QMS audit within 30 working days in accordance with relevant requirements.

When considering that it is necessary to carry out QMS audit for an imported Class II/III medical device during the technical review, the CMDE of CFDA shall inform its Center for QMS Audit to conduct the QMS audit in accordance with relevant requirements, and shall participate in the audit when necessary.

The time used for QMS audit shall not be included in the period laid down for the technical review.

Article 35 Where supplements and corrections are required to be made by the applicant during the technical review, the Center for Medical Device Evaluation of the Food and Drug Administration authority shall, on a single occasion, inform the applicant of all the contents that need to be supplemented and corrected. The applicant shall provide the supplementary dossiers one time as required within one year based on the Notice of Supplementation and Correction. The Center for Medical Device Evaluation shall complete the technical review within 60 working days upon the date of receiving supplementary dossiers. The expiry of the period laid down for the technical review shall be suspended from the date of the Notice of Supplementation and Correction until such time as the supplementary dossiers have been received.

When having any objection to the Notice of Supplementation and Correction, the applicant may advance its written opinions to the corresponding Center for Medical Device Evaluation, provide justifications and submit the corresponding technical support information.

If the applicant fails to submit the supplementary dossiers within the time limit, the Center for Medical Device Evaluation shall terminate the technical review and put forward the suggestions of not approving the application, and the Food and Drug Administration authority shall make the final decision of disapproval after ratifying the suggestions put forward by its Center for Medical Device Evaluation.

Article 36 The Food and Drug Administration authority that accepts the registration application shall make a decision within 20 working days after the conclusion of the technical review. The medical device meeting the requirements of safety and effectiveness shall be approved to be registered, in which case, the Medical Device Registration Certificate shall be issued to the applicant within 10 working days upon the date when the approval decision is made, and the approved Product Technical Requirements (PTR) shall be annexed to the Certificate. If the registration application is not approved, the Food and Drug Administration authority shall provide a written justification for disapproval and inform the applicant of its right to request a reexamination and apply for administrative reconsideration or lodge an administrative lawsuit according to law.

The Medical Device Registration Certificate is valid for five years.

Article 37 Medical device registration items include licensing items and registered items. Licensing items include the name, model, specification, structure and components, scope of application, and Product Technical Requirements (PTR) of a medical device, as well as the manufacturing site of an imported medical device. Registered items include the name and address of the MAH, the name and address of the Agent, and the manufacturing site of a domestic medical device.

Article 38 As for a medical device used for treating rare diseases or urgently needed for dealing with public health emergencies, when approving the registration of this medical device, the Food and Drug Administration authority has the right to require the applicant to further complete the relevant work after the device is approved to enter the market, and specify the corresponding requirements in the Medical Device Registration Certificate.

Article 39 For an accepted registration application, the Food and Drug Administration authority shall make a decision of disapproval under any of the following circumstances and inform the applicant:

(1)    The application dossiers submitted by the applicant cannot prove the safety and effectiveness of the medical device to be placed on the market;

(2)    The application dossiers are false;

(3)    Contents of the application dossiers are confusing and contradictory;

(4)    Contents of the application dossiers are obviously inconsistent with the application items;

(5)    Other circumstances under which the registration application shall not be approved.

Article 40 For an accepted registration application, the applicant can apply to the Food and Drug Administration authority accepting the application for withdrawal of the registration application and relevant dossiers before the decision of administrative permission is made, and provide a justification accordingly.

Article 41 The Food and Drug Administration authority has the right to suspend the review and approval of an accepted registration application if there is evidence that the application dossiers may be false. After verification, the Food and Drug Administration authority shall continue the review process or make a decision of disapproval based on the verification results.

Article 42 When having any objection to the decision of disapproval made by the Food and Drug Administration authority, the applicant can, within 20 working days upon the date of receiving the Notice of Disapproval, apply to the Food and Drug Administration authority that makes the decision for a reexamination. The contents of the reexamination application are limited to the original application items and the original application dossiers.

Article 43 The Food and Drug Administration authority shall make a decision for the reexamination within 30 working days upon the date of accepting the reexamination application, and inform the applicant of the decision in writing. If the original decision is upheld, the Food and Drug Administration authority will not accept the further application for reexamination submitted by the applicant.

Article 44 If the applicant has an objection to the decision of disapproval made by the Food and Drug Administration authority and has applied for administrative reconsideration or lodged an administrative lawsuit hereinto, the Food and Drug Administration authority will not accept the application for reexamination submitted by the applicant.

Article 45 If the Medical Device Registration Certificate is lost, the MAH shall immediately publish a loss statement in the media designated by the original certificate-issuing authority. The MAH can apply to the original certificate-issuing authority for the re-issuance of the Certificate one month after the date of publication of the loss statement, and the original certificate-issuing authority shall reissue the Certificate within 20 working days.

Article 46 If the application for registration of a medical device is directly related to the vital interests between the applicant and other parties, the Food and Drug Administration authority shall inform the applicant and the interested parties that they have the right to apply for a hearing according to laws, regulations, and other CFDA provisions. If major licensing items involving the public interest are found during the review of the application for registration of a medical device, the Food and Drug Administration authority shall announce to the public and hold a hearing.

Article 47 As for a newly-developed medical device that has not yet been listed in the Classification Catalogue for Medical Devices, the applicant may directly apply to CFDA for registration of a Class III medical device, or apply for product registration or recording after judging the product classification based on the classification rules and applying to CFDA for the classification determination.

As for a medical device directly applied for registration as a Class III medical device, CFDA shall determine the classification according to the risk level of the device. In case that a domestic medical device is classified as Class II, CFDA shall forward the application dossiers to the Food and Drug Administration authority at the level of province, autonomous region or municipality where the applicant is located for review and approval. In case that a domestic medical device is classified as Class I, CFDA shall forward the application dossiers to the Food and Drug Administration authority at the level of city with sub-districts where the applicant is located for recording.

Article 48 Any patent dispute occurring during the review process or after the approval of the registration application shall be settled in accordance with the relevant laws and regulations.

 

Chapter VI - Registration Change

Article 49 In case of changes to the contents specified in the Medical Device Registration Certificate (including the Attachment) of an approved Class II/III medical device, the MAH shall apply to the original Food and Drug Administration authority responsible for the registration approval for registration change and submit application dossiers in accordance with relevant requirements.

In case of changes to the name, model, specification, structure and components, scope of application, or Product Technical Requirements (PTR) of a medical device, or the manufacturing site of an imported medical device, the MAH shall apply to the original Food and Drug Administration authority responsible for the registration approval for the change of licensing items.

In case of changes to the name or address of the MAH, or the name or address of the Agent, the MAH shall apply to the original Food and Drug Administration authority responsible for the registration approval for the change of registered items; in case of changes to the manufacturing site of a domestic medical device, the MAH shall apply for the change of registered items after the change of the corresponding Manufacturing License has been completed.

Article 50 If the application dossiers for the change of registered items meet relevant requirements, the Food and Drug Administration authority shall issue the Approval Document for Medical Device Registration Change within 10 working days. If the application dossiers for the change of registered items are incomplete or fail to meet the requirements of formal examination, the Food and Drug Administration authority shall, on a single occasion, inform the applicant of all the contents that need to be supplemented and corrected.

Article 51 As for the application for change of licensing items, the Center for Medical Device Evaluation shall focus on the changes during the review process, and evaluate whether the changed device is still safe and effective.

The Food and Drug Administration authority that accepts the application for change of licensing items shall organize the technical review in line with the time limit set forth in Chapter V.

Article 52 The Approval Document for Medical Device Registration Change shall be used along with the original Medical Device Registration Certificate, and its validity period shall be the same as that of the original Registration Certificate. After acquiring the Approval Document for Medical Device Registration Change, the MAH shall modify the Product Technical Requirements (PTR), Instructions for Use and labels accordingly.

Article 53 The relevant provisions set forth in Chapter V shall apply with the proviso that the procedures for accepting, reviewing and approving the application for the change of licensing items are not provided for in this Chapter.

 

Chapter VII - Registration Renewal

Article 54 If the Medical Device Registration Certificate needs to be renewed due to expiry, the MAH shall apply to the original Food and Drug Administration authority responsible for the registration approval for registration renewal no later than six months prior to the expiry date of the Certificate, and submit application dossiers in accordance with relevant requirements.

With the exception of the circumstances specified in Article 55, the Food and Drug Administration authority that receives the application for registration renewal shall make a decision on whether to approve the renewal application or not before the expiry date of the Medical Device Registration Certificate. If the Food and Drug Administration authority fails to make a decision within the time limit, the renewal application shall be deemed to have been approved.

Article 55 Under any of the following circumstances, the application for registration renewal shall not be approved:

(1)    The MAH fails to apply for registration renewal within the stipulated time;

(2)    The mandatory standards for medical devices have been revised, while the medical device under discussion fails to meet the new requirements;

(3)    As for a medical device used for treating rare diseases or urgently needed for dealing with public health emergencies, the Food and Drug Administration authority has put forward some requirements when approving the registration application, while the MAH fails to complete the items specified in the Medical Device Registration Certificate within the stipulated time.

Article 56 The relevant provisions set forth in Chapter V shall apply with the proviso that the procedures for accepting, reviewing and approving the application for registration renewal are not provided for in this Chapter.

 

Chapter VIII - Product Recording

Article 57 A Class I medical device shall be approved through recording before being manufactured.

Article 58 To apply for medical device recording, the recording applicant shall submit recording application dossiers in accordance with Article 9 of the Regulations on the Supervision and Administration of Medical Devices.

If the recording application dossiers meet the relevant requirements, the Food and Drug Administration authority shall approve the recording application on the spot. If the recording application dossiers are incomplete or fail to conform to the prescribed format, the Food and Drug Administration authority shall, on a single occasion, inform the recording applicant of all the contents that need to be supplemented and corrected, and approve the recording application after all the required supplements and corrections have been made by the recording applicant.

If the application for recording of a medical device is approved, the Food and Drug Administration authority shall issue the Recording Certificate in accordance with the required format and publish the information specified in the Recording Information Sheet on its website.

Article 59 In case of changes to the contents specified in the Recording Information Sheet or changes to the approved Product Technical Requirements (PTR) of an approved Class I medical device, the MAH shall apply to the original Food and Drug Administration authority responsible for the recording approval for the change of recording information by submitting a description of the changes along with relevant supporting documents. If the application dossiers for the change of recording information meet the formal requirements, the Food and Drug Administration authority shall specify the changes in "Information Changed" and archive the application dossiers.

Article 60 In case that an approved Class I medical device is reclassified to a higher level of risk, the MAH shall take the initiative to apply to the original Food and Drug Administration authority responsible for the recording approval for withdrawal of the original recording. If the device is reclassified as Class II/III, the registration application shall be submitted in accordance with the relevant requirements set forth in these Provisions.

 

Chapter IX - Supervision and Administration

Article 61 CFDA is responsible for the supervision and administration of medical device registration and recording nationwide, and for supervising and guiding the review and approval of medical device registration and recording applications by local Food and Drug Administration authorities.

Article 62 The Food and Drug Administration authorities at the level of province, autonomous region or municipality are responsible for the supervision and administration of the medical device registration and recording within their respective administrative areas, and for organizing supervision and inspection and timely reporting the relevant situation to CFDA.

Article 63 The Food and Drug Administration authorities at the level of province, autonomous region or municipality shall, based on the principle of local administration, carry out routine supervision and administration of the Agents concerning the registration/recording of imported medical devices.

Article 64 The Food and Drug Administration authorities at the level of city with sub-districts shall inspect the work concerning medical device recording at regular intervals, and timely report relevant information to the Food and Drug Administration authorities at the level of province, autonomous region or municipality.

Article 65 In case that the Registration Certificate of an approved Class II/III medical device shall be cancelled in accordance with relevant laws and regulations, or that the MAH voluntarily applies for certificate cancellation before the expiry date of the Registration Certificate, the Food and Drug Administration authority shall cancel the Registration Certificate according to law and announce such results to the public.

Article 66 In case that an approved Class II/III medical device is reclassified to a lower level of risk, the Registration Certificate shall remain valid within its period of validity. If the Registration Certificate needs to be renewed due to expiry, the MAH shall, based on the reclassification, apply to the corresponding Food and Drug Administration authority for registration renewal or product recording no later than six months prior to the expiry date of the Certificate.

In case that an approved Class I/II medical device is reclassified to a higher level of risk, the MAH shall, based on the reclassification, apply to the corresponding Food and Drug Administration authority for product registration in accordance with the requirements set forth in Chapter V. CFDA shall stipulate the time limit for completing the reclassification in the Notice of Medical Device Reclassification.

Article 67 In case that the Food and Drug Administration authority at the level of province, autonomous region or municipality approves the registration application of a medical device in violation of the requirements of these Provisions, CFDA shall order the authority involved to take corrective measures within a time limit. If the authority fails to take corrective measures within the time limit, CFDA can directly announce the revocation of the Medical Device Registration Certificate involved issued by this authority.

Article 68 The Food and Drug Administration authorities, related functional centers and their staff shall be obligated to keep confidential the experimental data and technical secrets submitted by the registration/recording applicants.

 

Chapter X - Legal Liabilities

Article 69 Any party that obtains the Medical Device Registration Certificate by providing false information or by other deceptive means shall be punished in accordance with the first paragraph of Article 64 of the Regulations on the Supervision and Administration of Medical Devices.

Any party that provides false information when applying for product recording shall be punished in accordance with the second paragraph of Article 65 of the Regulations on the Supervision and Administration of Medical Devices.

Article 70 Any party that forges, alters, transacts, leases or lends the Medical Device Registration Certificate shall be punished in accordance with the second paragraph of Article 64 of the Regulations on the Supervision and Administration of Medical Devices.

Article 71 Any party that fails to apply for the change of recording information (Class I) or the change of registered items (Class II/III) in accordance with the requirements set forth in these Provisions shall be punished according to the provisions concerning the circumstances of "failure to record" set forth in the Regulations on the Supervision and Administration of Medical Devices.

Article 72 Any party that fails to apply for the change of licensing items (Class II/III) in accordance with the requirements set forth in these Provisions shall be punished according to the provisions concerning the circumstances of "failure to obtain the Medical device Registration Certificate" set forth in the Regulations on the Supervision and Administration of Medical Devices.

Article 73 If the applicant fails to carry out clinical trials in accordance with the Regulations on the Supervision and Administration of Medical Devices and these Provisions, the Food and Drug Administration authority at or above the county level shall order the applicant to take corrective measures, and the applicant can be imposed a fine of no more than ¥ 30,000. In serious cases, the clinical trials shall be stopped immediately, and the letter of approval for clinical trials, if any, shall be cancelled accordingly.

 

Chapter XI - Supplementary Provisions

Article 74 In principle, the medical device registration/recording unit shall be divided based on the technical principle, structure and components, performance indicators and scope of application of medical devices.

Article 75 The combining components listed in the column of "Structure and Components" in the Medical Device Registration Certificate can be distributed separately if these components are used for the original approved device for the purpose of replacement of consumables, after-sales service and maintenance.

Article 76 The format of the Medical Device Registration Certificate shall be uniformly formulated by CFDA.

The layout of Registration Certificate number is as follows:

 “×1械注×2××××3×4××5××××6”. Where,

"×1" stands for the short name of the place where the Food and Drug Administration authority responsible for the review and approval of the registration application is located:

In case of a domestic Class III medical device or an imported Class II/III medical device, the Chinese character "" shall apply;

In case of a domestic Class II medical device, the short name of the province, autonomous region or municipality where the Food and Drug Administration authority responsible for the review and approval of the registration application is located shall apply;

"×2" stands for the registration type:

The Chinese character "" is applicable to a domestic medical device;

The Chinese character "" is applicable to an imported medical device;

The Chinese character "" is applicable to a medical device manufactured in Hong Kong, Macao or Taiwan.

"××××3" stands for the year in which the application for initial registration of a medical device is approved;

"×4" stands for the regulatory classification of a medical device;

"××5" stands for the classification code of a medical device;

"××××6" stands for the serial number produced when the application for initial registration of a medical device is approved.

In the case of registration renewal, "××××3" and "××××6" will remain unchanged. Where a medical device is reclassified, the Registration Certificate shall be renumbered.

Article 77 The layout of Recording Certificate number for a Class I medical device is as follows:

"×1械备××××2××××3号".

Where,

"×1" stands for the short name of the place where the Food and Drug Administration authority responsible for the recording approval is located:

In case of an imported Class I medical device, the Chinese character "" shall apply;

In case of a domestic Class I medical device, the short name of the province, autonomous region or municipality plus the short name of the city with sub-districts where the Food and Drug Administration authority responsible for the recording approval is located shall apply (where the city with sub-districts does not exist, only the short name of the province, autonomous region or municipality shall apply);

"××××2" stands for the year in which the application for recording of a medical device is approved;

"××××3" stands for the serial number produced when the application for recording of a medical device is approved.

Article 78 For the registration and recording of an IVD reagent regulated as a medical device, the Provisions on Registration of IVD Reagents shall apply.

Article 79 The Emergency Approval procedures for Medical Devices and the Expedited Approval Procedures for Innovative Medical Devices shall be separately formulated by CFDA.

Article 80 As needed, CFDA may commission the Food and Drug Administration authorities at the level of province, autonomous region or municipality (or their functional centers) and relevant social organizations to undertake specific work related to medical device registration.

Article 81 The charging items and charging standards of medical device registration shall be executed in accordance with the relevant provisions of the competent authorities of finance and price control under the State Council.

Article 82 These Provisions shall apply from October 1, 2014. The Provisions on Medical Device Registration (SFDA Order No. 16 in 2004) promulgated on August 9, 2004 will be abolished simultaneously.

 


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